实时荧光核酸恒温扩增技术检测宫颈解脲支原体的应用价值  

Application value of real-time fluorescent nucleic acid isothermal amplification technology in detecting Ureaplasma urealyticum in the cervix

作　　者：朱寅 宁玉梅 ZHU Yin;NING Yumei(Department of Obstetrics,The Third Affiliated Hospital of Soochow University,Changzhou 213003,China;Clinical Medicine College,Hangzhou Normal University,Hangzhou 311121,China;Zhejiang Provincial Maternal and Child and Reproductive Health Center,Hangzhou 310012,China)

机构地区：[1]苏州大学附属第三医院产科,江苏常州213003 [2]杭州师范大学临床医学院,浙江杭州311121 [3]浙江省妇幼和生殖保健中心,浙江杭州310012

出　　处：《健康研究》2025年第1期101-106,共6页Health Research

基　　金：浙江省中医药科技计划项目(2020ZB113)。

摘　　要：目的对比实时荧光核酸恒温扩增技术(simultaneous amplification and testing,SAT)和聚合酶链反应(polymerase chain reaction,PCR)在解脲支原体(Ureaplasma urealyticum,UU)感染治疗后的检测效果差异,为探寻随访中实时评估疗效的检测方法以避免过度治疗提供参考。方法分别在患者初检和治疗后停药2周及以下、停药2周以上复诊时,采用液体培养法、PCR法、SAT法检测UU,记录3种方法的结果报告时间;以液体培养法为标准,计算PCR法、SAT法的灵敏度、特异度、假阳性率,用配对设计四格表资料卡方检验(McNemar)比较PCR和SAT 2种检测方法与液体培养法检测UU的阳性率,绘制受试者工作曲线并计算出曲线下面积(area under curve,AUC)以评估PCR法与SAT法的检测效果差异。结果除去样本保存和运输时间,从样本接收到报告结果,液体培养法耗时约45 h,PCR法耗时约11 h,SAT法耗时约6 h。治疗后随访4周,停药2周及以下时,PCR法检测UU的灵敏度为87.5%(7/8),特异度为38.5%(5/13),假阳性率61.5%(8/13),AUC为0.630(95%CI:0.386~0.873),与液体培养法的结果比较,差异有统计学意义(χ^(2)=4.00,P=0.039);SAT法的检测灵敏度为87.5%(7/8),特异度为84.6%(11/13),假阳性率为15.4%(2/13),AUC为0.861(95%CI:0.682~1.000),与液体培养法的结果差异无统计学意义(χ^(2)=0.000,P=1.000)。治疗前筛查和停药2周以上时,PCR和SAT检测UU的结果与液体培养法的结果差异均无统计学意义(P>0.05)。结论与PCR相比,SAT报告时间短,复查时假阳性率更低,因此SAT兼顾快速和准确,更适合治疗后停药时间≤2周的患者复查。Objective To compare the detection performance of real-time fluorescent nucleic acid isothermal amplification technology(simultaneous amplification and testing,SAT)with that of polymerase chain reaction(PCR)in identifying Ureaplasma urealyticum(UU)infection following treatment,and to provide insights for real-time therapeutic efficacy evaluation during follow-up to avoid overtreatment.Methods UU detection was performed using liquid culture,PCR,and SAT methods during patients'initial screening and at follow-up visits-categorized by medication discontinuation durations of≤2 weeks and>2 weeks post-treatment.The reporting times for all three methods were recorded.Using the liquid culture method as the reference standard,the sensitivity,specificity,and false-positive rate of the PCR and SAT methods were calculated.A paired 2×2 contingency table analysis via McNemar's chi-square test was conducted to compare the positive detection rates of PCR and SAT with those of the liquid culture method.Receiver operating characteristic(ROC)curves were constructed,and the area under the curve(AUC)was calculated to assess performance differences between PCR and SAT.Results Excluding sample preservation and transportation times,the elapsed time from sample receipt to result reporting was approximately 45 hours for the liquid culture method,11 hours for PCR,and 6 hours for SAT.At a 4-week post-treatment follow-up,in cases with medication discontinuation for≤2 weeks,the PCR method yielded a sensitivity of 87.5%(7/8),a specificity of 38.5%(5/13),a false-positive rate of 61.5%(8/13),and an AUC of 0.630(95%CI:0.386-0.873);these differences compared to the liquid culture method were statistically significant(χ^(2)=4.00,P=0.039).Conversely,the SAT method demonstrated a sensitivity of 87.5%(7/8),a specificity of 84.6%(11/13),a false-positive rate of 15.4%(2/13),and an AUC of 0.861(95%CI:0.682-1.000),with no statistically significant differences relative to the liquid culture method(χ^(2)=0.000,P=1.000).For pre-treatment screening and

关 键 词：解脲支原体 液体培养法 实时荧光核酸恒温扩增检测技术 聚合酶链反应 实时评估 

分 类 号：R711.32[医药卫生—妇产科学]